Lipowear

ABSTRACT

Contemplated padded undergarments are form-fitted and have a higher than normal ratio of waist circumference to leg circumference and include a padded area that covers substantially the entire contact area of buttocks and legs with a chair when a person wearing such undergarment is sitting on the chair. Such undergarments are particularly advantageous to provide symptomatic relief for a person diagnosed with HIV infection, a neoplastic disease, chronic diabetes, and/or advanced age, which is typically accompanied by lipoatrophy, lipodystrophy, and/or sarcopenia.

This application claims the benefit of our copending U.S. patentapplication with the Ser. No. 11/277,818, which was filed Mar. 29, 2006.

FIELD OF THE INVENTION

The field of the invention is functional clothing, especially as itrelates to undergarments with a padding that is configured to alleviatesymptomatic discomfort associated with various conditions, andparticularly lipodystrophy, lipoatrophy, and/or sarcopenia.

BACKGROUND OF THE INVENTION

Various conditions and diseases are associated with loss ormaldistribution of body mass, and especially fat and muscle tissue. Forexample, long-term treatment of patients infected with the HIV virus isoften accompanied by lipodystrophy, lipoatrophy, and/or sarcopenia.Similar problems are also encountered by patients undergoingchemotherapy for treatment of cancer, and/or long-term diabetespatients.

While pain due to lipodystrophy, lipoatrophy, peripheral neuropathy,and/or sarcopenia can be treated with analgesics, drug therapy is oftennot desirable due to high costs and/or side effects of the drugs. Mostsignificantly, loss of body mass, and especially loss of fatty tissue inthe buttocks and legs typically lead to tenderness, and more typicallysevere pain in such patients which transforms routine daily activities(e.g., sitting on a chair, lacing shoes) into a challenge. Thus, thequality of life is significantly reduced and even prevents at least someof these patients from participation in ordinary daily life. Remarkably,there are numerous garments known in the art that increase sittingcomfort of a person on bicycle seat or provide cushioning for sportsactivities, however, none of them has been shown to substantiallyalleviate personal discomfort for patients having lipodystrophy,lipoatrophy, peripheral neuropathy, and/or sarcopenia.

For example, U.S. Pat. No. 4,984,304 describes an undergarment with apad that shapes and uplifts the lower buttocks for cosmetic reasons.Clearly, such undergarment is not suitable for patients withlipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia andfurther fails to significantly cushion affected areas. In anotherexample, as shown in U.S. Pat. No. 4,969,216, an undergarment has alarge unitary cushion that is configured to cover the buttocks area.While at least some protection is provided to the pericoxxigeal area,the side and back of the legs, and the waist area remains unprotected.

Still further known undergarments with a pair of cushioned inserts areshown in U.S. Pat. No. 4,894,867, in which the pads are relatively smalland designed for sports events. Similarly, even smaller and very thinbuttock-protecting pads are provided in a comfort garment as shown inU.S. Pat. Nos. 5,103,505 and 5,749,101. Sport pants with larger paddingare described in U.S. Pat. No. 5,649,328, in which inner, tight-fitting,and outer, loose-fitting shorts include inner and outer pads,respectively to provide cushioning to an in-line skater in case of afall. While such garments are generally suitable for their intendedpurpose, the padding is either too small to effectively protect back andlegs of a person, or the sports garment is too bulky to be worn asundergarment. In yet other known garments, the cushioning pad has aunitary construction that extends across the crotch and is typicallyused in bicycling shorts as depicted in U.S. Pat. Nos. 4,961,233,4,805,243, 5,365,610, and 5,271,101, and U.S. Pat. App. No.2003/0131399. While such shorts typically significantly improve sittingcomfort on a bicycle seat, the cushioning area is limited to the crotcharea, which is of little or no help to a person suffering fromlipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia.

Therefore, while numerous padded pants and undergarments are known inthe art, all or almost all of them suffer from one or moredisadvantages. Thus, there is still a need for improved undergarmentsthat effectively and discreetly provide cushioning for the legs,buttocks, and belt area of a person wearing such garment.

SUMMARY OF THE INVENTION

The present invention is directed to undergarments and methods therefor,and especially to form-fitted undergarments having a waist portion witha waist circumference and a leg portion with a leg circumference,wherein the ratio of the waist circumference to the leg circumference ishigher than normal. Such undergarments include a padded area configuredto provide preferably continuous protection extending from an upper areaof the waist portion to a lower area of the leg portion such that thearea of the buttocks and legs of a person contacting a seat (whilesitting on a chair) are substantially completely covered by the paddedarea.

Most typically, the higher than normal ratio is characteristic of aperson diagnosed with lipoatrophy, lipodystrophy, sarcopenia, HIVinfection, a neoplastic disease, and/or chronic diabetes. For example,such contemplated ratios will be at least 1.9, and more typically atleast 2.0 (as compared to a normal ratio of about 1.6 to 1.8, or lower).It is typically preferred that at least one of the waist portion and theleg portion comprises an elastic material, and/or the padded areaextends to a substantially topmost and/or lowermost end of the waistportion and/or leg portion. Where desirable, the padded area isconfigured as an independent right and left area, wherein each areaincludes a removable pad. Furthermore, it is contemplated that thepadded area and/or pad includes a plurality of vent openings and that itis further contoured to have a thicker than average thickness in thebuttock area and optionally a thinner than average thickness in aperipheral area of the padded area.

In another aspect of the inventive subject matter, a method of providingsymptomatic relief for a person suffering from HIV infection, chronicdiabetes, neoplastic disease, lipoatrophy, lipodystrophy, and/orsarcopenia will comprise a step of providing the form-fittedundergarment according to inventive subject matter and a furtheroptional step of informing the person that the undergarment reducessymptomatic discomfort associated with the conditions indicated above.Moreover, contemplated undergarments may also be of significantadvantage where the patient is a geriatric patient as advanced age isoften accompanied by loss of muscle tissue and/or fatty tissue in thebuttocks and/or legs.

Alternatively, or additionally, a method of providing improved sittingcomfort to a person is contemplated in which a form-fitted undergarmenthaving a waist portion, a leg portion, and a padded area is provided,wherein the padded area is configured to provide protection extendingfrom an upper area of the waist portion to a lower area of the legportion such that the area of the buttocks and legs of a personcontacting a seat (while sitting on a chair) are substantiallycompletely (i.e., at least 90%, more typically at least 95%) covered bythe padded area. In another step, the person is informed that theundergarment will provide reduction in at least one of pain, numbness,local hemostasis, and deep vein thrombosis when the garment is wornduring a prolonged period of sitting (e.g., over at least one, moretypically at least two, and most typically at least three hours). Mostpreferably, the padded area in such methods has an average thickness ofbetween 0.5 inch to 1 inch, and is contoured to have a thinner thanaverage thickness in a peripheral area of the padded area. Furthermore,it is generally preferred that the padded area is configured as anindependent right and left area, wherein each area includes a removablepad.

Various objects, features, aspects and advantages of the presentinvention will become more apparent from the following detaileddescription of preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a photograph of a front view of an exemplary undergarmentaccording to the inventive subject matter.

FIG. 2 is a photograph of a rear view of the undergarment of FIG. 1.

FIG. 3 is a photograph of a padding insert of the undergarment of FIG.1.

FIG. 4 is a photograph of the foam pad of the padding insert of FIG. 3.

FIGS. 5A-5C depict top view (A), bottom view (B), andschematic/cross-sectional view (C) of the foam pad used in the clinicalstudy reported herein.

FIG. 6 is a graph illustrating the increase of length of sitting withoutdiscomfort in study participants using the undergarment according to theinventive subject matter.

DETAILED DESCRIPTION

The inventor has discovered that quality of life of a person diagnosedwith lipodystrophy, lipoatrophy, peripheral neuropathy, and/orsarcopenia can be significantly improved by providing a form-fittedundergarment that not only accommodates the altered anatomical featuresof such persons, but that also provides a relatively large padding tothereby reduce painful and potentially destructive pressure to the legsand buttocks during sitting.

It should be noted that patients diagnosed with the above conditionswill typically exhibit a substantially reduced amount of muscle and/orfat tissue in the buttock area and/or the posterior thigh area, whichexposes muscles, nerves, and blood vessels to significant compressionand thus renders sitting even over a relatively short period not onlypainful but also potentially damaging to the compressed tissues.Unfortunately, loss of functional vasculature and neuropathic pain areoften common in such compressed tissues and further decrease sense ofwell-being for geriatric and/or patients diagnosed with the conditionslisted above. Viewed from a different perspective, undergarmentsaccording to the inventive subject matter will not only distribute theweight of a sitting person from a few compression points to a relativelylarge area, but will also provide cushioning to the load-bearing surfaceof a body while the person is in a sitting position. Therefore,contemplated undergarments will significantly increase quality of life,allowing normal daily activities and social life, and thereby reducingdepression and use of analgesics.

In one particularly preferred aspect of the inventive subject matter,the undergarment is configured as a form-fitting undergarment asdepicted in FIG. 1. Here undergarment 100 has a waist portion 110 withan elastic waistband 112 and optional drawstring 114. The leg portion120 includes first and second legs 122A and 122B. Waist circumference isschematically indicated by arrow W, while leg circumference isschematically indicated by arrow L. In preferred aspects of theinventive subject matter, the ratio of the waist circumference W to legcircumference L in contemplated undergarments is higher (e.g., about1.9-2.1) than a W to L ratio ordinarily encountered in form-fittedundergarments (e.g., about 1.6-1.8). While not limiting to the inventivesubject matter, it is generally preferred that the waist is elasticizedto allow a person to wear the undergarment above, at, or below the hipbones. Thus such garment can be worn with or without belt, or with looseor close fitted clothing.

Pads 130A and 130B are disposed in respective pouches (not shown), whichare formed in the rear of the undergarment 100. FIG. 2 depicts a rearview of the undergarment 100 of FIG. 1. Here, the positioning andconfiguration of the pads 230A and 230B is more readily apparent. Mostsignificantly, it should be noted that the pads in the exemplaryembodiment are two separate pads that extend along the length X from theupper area of the waist portion to the lower area of the leg portion. Insuch exemplary undergarment, it should be noted that X is between about75% to 95%, more typically about 80% to 95%, and most typically about90% to 95% of the entire length of the garment. Similarly, the padsextend along the width Y from one side of the leg to the other side ofthe leg, wherein Y is typically at least 30% to 40%, and more typicallyat least 35% to 50% of the leg circumference L. The term “about” as usedherein in conjunction with a numeral refers to a range of the numeral of+/−5%, inclusive.

FIG. 3 depicts the removable pad insert 330 of one side of theundergarment, while FIG. 4 shows the contoured foam pad that is normallycontained in a textile envelope to thereby form the pad insert of FIG.3. Here peripheral area 432 has a lower than average thickness(typically between ¼ inch and less than ¾ inch), while the area proximaland overlapping the buttock area 442 has a higher than average thickness(typically between more than ¾ inch and 1 inch). A substantiallyhorizontal seam may be included that assists in formation of a pad shapesimilar to a normal anatomy of buttocks. Vent openings 436 and lateralcuts 438 assist in heat and moisture transport across the pad andfurther allow for extra deformation. Of course, while the exemplaryundergarment of FIG. 1 is depicted for male to users, it should berecognized that modifications known in the art can be made toaccommodate female and/or pediatric users as well. It should be notedthat contemplated pads and pad inserts may also have flex grooves and/orflex hinges that allow to the pad to conform to a persons anatomy whilethe person is moving. Among other advantages, such flexibility willreduce or even entirely eliminate the possibility for the undergarmentto ride up or chaff during walking and sitting.

Thus, it should be recognized that a (preferably form-fitted)undergarment will typically include a waist portion with a waistcircumference and a leg portion with a leg circumference, wherein theratio of waist to leg circumference is higher than a normal ratio (seebelow). Such unusual ratio is not only considered beneficial inretaining the padded area in a desired place (prevents the pads from‘flopping around’), but is also though to provide support for theanatomical areas covered. Where the fit is relatively tight, suchsupport may also provide drainage and/or vascular support. It is furthergenerally preferred that a padded area is included that is configured toprovide protection that extends from an upper area of the waist portionto a lower area of the leg portion. The protection is typically suchthat the area of the buttocks and legs of a person contacting a seat(while sitting on a chair) are substantially completely covered by thepadded area. The term “form-fitted” as used herein and with respect to agarment refers to a fit of a garment that generally follows the anatomyof a person. Therefore, and most typically, form-fitted undergarmentswill be in substantial complete (i.e., at least 80%, more typically atleast 90%) contact with the persons body when worn by the person. Whilenot limiting to the inventive subject matter, the waist portion and/orthe leg portion will comprise an elastic material that assists in theform fit. As also used herein and with respect to a person, the term“ratio of waist to leg circumference is higher than a normal ratio”means that the person's leg circumference relative to the person's waistcircumference is abnormally greater than the same ratio of an averagehealthy person. In most cases, a higher than normal ratio is observedwhere the leg circumference is significantly reduced due to lipoatrophyand/or sarcopenia (which may be precipitated by a disease and/oradvanced age [e.g., older than 65, and more typically older than 75years]). Such higher than normal ratio may also (and/or further) beprecipitated by exacerbated lipid accumulation around a person's waist(e.g., due to lipodystrophy) while having a normal or reduced legcircumference.

For example, a healthy person with a waist circumference (measured atabout the navel) of about 34 to 40 inches will typically have a legcircumference (measured at about midpoint between knee joint and hipjoint) of between about 20 and 24, resulting in a typical ratio ofbetween about 1.60 to 1.80, and even lower. In contrast, in a personwith abnormal and reduced leg circumference and possible increased waistcircumference, the ratio will typically be between about 1.9 to 2.2, andeven higher. Most commonly, and viewed from a different perspective,ratios that are considered higher than normal will be thosecharacteristic of a person diagnosed with lipoatrophy, lipodystrophy,sarcopenia (e.g., due to HIV infection, neoplastic disease, advancedage, and/or chronic diabetes). For example, higher than normal ratioswill be at least 1.85, more typically at least 1.9, even more typicallyat least 2.0, and most typically at least 2.1.

It is further generally preferred that the padded area in contemplatedundergarments will extend to the substantially topmost end of the waistportion and/or the substantially lowermost end of the leg portion. Thus,the length X of the padded area is preferably at least 70%, morepreferably at least 80%, even more preferably at least 90%, and mostpreferably at least 92% of the entire length of the undergarment. Itshould be noted that such extensive length of the padded area will notonly provide the lower portion of the legs with sufficient padding, butalso protect the spinal area around the iliac crest from pressure of abelt worn with pants. Thus, the upper end of the padding in at leastsome of the embodiments is configured such that the padding extends to aposition that is at, or even above the iliac crest of the hip bone whenthe undergarment is worn. In less preferred aspects, however, the upperend of the padded area may also extend to a position below the iliaccrest (e.g., 1 cm below, less preferably 2 cm below, and even lesspreferably 2-6 cm).

With respect to the lower end of the padding, it is typically preferredthat the lower end extends (preferably at least) to a position thatcorresponds to a portion of a leg in contact with a chair when a personsits on a chair. Therefore, viewed from another perspective, the lowerend of the padding extends to a position that corresponds to the lowerpoint of attachment of the adductor longus to the femoral bone, and evenlower (e.g., at least 1 cm, more typically at least 2 cm, and mosttypically at least 2-5 cm). Viewed from yet another perspective, thepadding extends to a position that is about 30 cm above the knee, moretypically between 30 cm and 20 cm above the knee, and most typicallybetween 20 cm and 10 cm above the knee (when the undergarment is worn ona person). With respect to the width Y of the padded area in the legportion, it is generally preferred that the padded area extends to atleast 30% of the leg circumference, and more typically at least 40% ofthe leg circumference. Viewed from a different perspective, the width(and length) of the padding is preferably selected such that the paddingwill cover the entire area of a leg and buttocks that would otherwisemake contact with a seat surface when the person wearing theundergarment is sitting on a chair. Consequently, it is contemplatedthat the ratio of padded area to the entire garment area (inside) isbetween about 20% to 80%, more typically between about 30% and 70%, andmost typically between about 35% and 65%.

Most typically, the padded area comprises an independent right area andleft area, each containing at least one padding element, which is mostpreferably a removable pad. However, in less preferred aspects, thepadded area may also comprise a single padding element covering bothsides of the body. The padded area and/or padding elements preferablycomprise a plurality of vent openings through which moisture and heatcan dissipate. It is still further preferred that the padded area and/orpadding element is further contoured to enhance it's functional and/oresthetic character. For example, it is typically preferred that thepadded area and/or padding elements have a thicker than averagethickness in the buttock area while having a thinner than averagethickness in the periphery of the padded area. The padding willpreferably comprises a molded, or shaped and precut foam pad, which willtypically be made of medical quality foam, high-grade furniture padding,memory foam, open cell foam, or other elastomeric material that willretain its shape over a prolonged period of use. Alternatively, it isalso contemplated that the padded area may comprise a plurality ofpadded elements that can preferably be individually inserted, exchanged,and/or removed to either personalize the undergarment to a particularbody shape, and/or to achieve a desirable body contour while wearing theundergarment. It should be noted that it is especially preferred thatthe undergarment according to the inventive subject matter is wornunderneath a regular pair of pants, and that the undergarment willtherefore serve at least two distinct functions. First and foremost,contemplated undergarments will reduce if not even eliminate subjectivediscomfort associated with sitting. Second, and especially where thewearer suffers from lipoatrophy and/or sarcopenia, contemplatedundergarments will provide a more desirable body profile when worn withrelatively tight fitting pants.

With respect to the padding material, it is generally contemplated thatall elastic materials are suitable, however, especially preferredmaterials have an elasticity such that the padding is compressed to lessthan about 60% (or less than 30-50%, or less than 50-60%, but also lessthan 60-70%, and even higher) of full compression when a person's weightcompresses the padding in use in garments contemplated herein.Therefore, suitable materials include high-grade synthetic foam commonlyused in medical uses and/or furniture trade, but also other materials,including memory foam, optionally foamed polymers (e.g., polyurethane,polyethylene, etc.), and all reasonable combinations thereof.Furthermore, it should be recognized that the padding may have athickness and/or density that is not even, especially where the materialis molded. For example, areas of higher weight load may have a greaterthickness as compared to areas where less weight load is commonlyexpected (e.g., side of the legs). Additionally, or alternatively, thepadding may be configured such that a user can adjust the thickness(e.g., by adding or removing material).

In further aspects of the inventive subject matter, it is contemplatedthat the padding may be permanently coupled to the garment (e.g.,directly sewn in, or enclosed in a pouch), or that the padding may betemporarily retained at a predetermined location (slipped into anenvelope, attached via hook-and-loop fasteners, buttons, snaps, etc.).Still further, in less preferred aspects, it is contemplated that theentire garment may be fabricated from a padding, wherein the areas to beprotected correspond to areas contemplated above and are of greaterthickness, while the non-protected areas may be fabricated from arelatively thin padding. The padding may thereby be added to the garmentin a manner such that the padding or portion thereof forms a portion ofa design element, or in a manner such that the padding is substantiallyinvisible from the outside of the garment when the garment is worn on aperson.

Regardless of the particular nature and configuration of the padding, itis contemplated that the non-padding portion of the undergarment may beformed from all materials known in the art, and particularly suitablematerials include cotton, synthetic and natural fibers, wool, and allreasonable combinations thereof. For example, especially suitablematerials include wicking fabrics, and particularly lycra, polyester,spandex, and all reasonable combinations thereof. Moreover, preferredmaterials also include fabric with added or built-in antimicrobialproperties. Still further, it is contemplated that padding to reducepainful conditions (e.g., due to lipodystrophy, lipoatrophy, and/orsarcopenia) may be included in clothing articles other thanundergarments. Therefore, contemplated alternative garments includeshorts, pants, shirts, shoes, socks, etc., wherein the padding isprovided in areas to reduce pressure to one or more anatomic structures.In still further contemplated aspects, the undergarment may also be madefrom a material with sufficient resiliency to allow formation of acompression garment that supports and compresses a wearers body.

Especially contemplated uses include those in which symptomatic relieffrom pain and other discomfort associated with HIV infection, chronicdiabetes, neoplastic disease, lipoatrophy, lipodystrophy, sarcopenia,and/or advanced age is provided by wearing the undergarment according tothe inventive subject matter. Additionally, the inventor observed thatcontemplated undergarments also provide relief from generalized ornon-specific hip and pelvic pain, which may be due to injury,osteoarthritis, and/or osteonecrosis (or other unknown etiology). Suchmethods may further include various steps of providing information thatthe undergarment will provide symptomatic relief, improve appearance,quality of life, and/or reduce pain in a person wearing theundergarment. Information may be provided in numerous manners, includingpictorial information, written description, and/or auditory information.Consequently, advantages and properties of contemplated undergarmentsmay be advertised on a sales brochure, on the packaging in which theundergarment is contained, in websites, etc. Therefore, target marketsfor such undergarments will include geriatric patients, HIV patients,post-surgical patients with hip and/or thigh bone surgery.

Further contemplated uses include those for healthy persons that aresubject to relatively long periods of sitting. For example, a method ofproviding improved sitting comfort to a person may include a step inwhich a form-fitted undergarment having a waist portion, a leg portion,and a padded area is provided, wherein the padded area is configured toprovide protection extending from an upper area of the waist portion toa lower area of the leg portion such that buttocks and legs of a personcontacting a seat while sitting on a chair are substantially completelycovered by the padded area (average thickness of between 0.5 inch to 1inch). In another step, the person is informed that the undergarmentprovides reduction in at least one of pain, numbness, local hemostasis,and deep vein thrombosis when the garment is worn during a period ofsitting over at least three hours. While such persons are typically ofadvanced age, younger persons are also expressly contemplated herein.With respect to the undergarment, materials, and dimensions, similar, oreven same considerations as described above apply.

EXAMPLES

To determine the impact of the form-fitted undergarments according tothe inventive subject matter in persons with lipoatrophy of the legs andbuttocks and sitting pain on sitting comfort, quality of life and theability to participate in sitting activities associated with variouslife activities, the following study was performed.

Product Tested

The form-fitted undergarment used in this study (LipoWear Shorts) hadthe following features: Foam pads were anatomically designed for sittingpain relief and had the general shape as depicted in FIGS. 5A-5C. As canbe seen from FIG. 5A, the top sides of the padding inserts were profiledtop-to-bottom and side-to-side, and included two non-perforating cutoutsto assist flexing of the padding in the central area of the buttocks.The bottom sides of the padding included a plurality of vent openingsperforating the thickness of the padding and having a geometry in whichthe opening proximal to the skin has a larger diameter that the openingdistal to the skin as shown in FIG. 5B. Moreover, a non-perforatingcutout was provided to assist flexing of the padding to conform to theposterior iliac crest. The vent openings were provided to allow heatloss, and the padding was further covered by a fabric layer on the skinside that allowed wicking of perspiration. An adjustable waist band wasprovided and the undergarment was form-fitted to be contoured to thebody. As can be seen from FIG. 5C, the padding was shaped such that atleast 70% of the top and bottom sides were profiled in a curved profileto both conform to the anatomy of the wearer but also to add material ina manner that would result in a more natural look of the wearer. Foampads were inserted into respective pockets of an elastic undergarmentthat was cut and sewn to be form fitted for a waist to leg circumferenceratio of at least 1.9.

Study Design

Subjects meeting the protocol criteria were enrolled in a two month,open label study at three HIV private practices in southern California.

Subject Inclusion Criteria: Male, small waist size at 28-30 inches ormedium waist size at 32-34 inches; age 18 or older; HIV-infected;presence of lipoatrophy in the legs and buttocks; presence of pain anddiscomfort when sitting; English speaking and capable of completingquestionnaires & diaries; able to complete 2 month study.

Subject Exclusion Criteria: Substance abuser; mental instability likelyto interfere with study participation; scheduled medical procedurerequiring hospitalization during 2 month study; allergic to syntheticfabrics or foam.

Main Outcome Measures

Sitting pain relief and Quality of Life improvement as measured byMultidimensional Quality of Life Questionnaire for Persons with HIV/AIDS(MQOL-HIV) developed by the New England Research Institutes, Inc. Fourof the ten domains in the MQOL-HTV where pain relief would potentiallyprovide a benefit were selected for analysis: Physical Function, SocialFunction, Cognitive Function and Mental Health. Each Domain had fourquestions. Each question was scored on a 7 point Likkert scale. Thescores for certain questions are reversed so that an increase in scorerepresents an increased quality of life. In addition, sleep restlessnesswas evaluated on a 5 point scale from not restless to extremelyrestless. Outcome measures were determined at baseline, 1 and 2 months.Statistical analysis compared baseline and month 2 endpoints.

Statistical Methodology

Sitting comfort time was evaluated using a one-sided t-test. Sleeprestlessness was evaluated using a one-sided, matched pairs t-test.Quality of Life mean scores were evaluated using two methodologies, thematched pairs t-test and the Wilcoxon sign-rank test, a nonparametrictest.

Results

31 subjects were enrolled in the study and 24 completed the two monthevaluation. Five subjects dropped out due to medical complications thatprevented them from making office visits. Two subjects dropped out dueto inappropriate size issues.

The mean age of the subjects completing the study was 53 and the meanlength of HIV antiviral treatment was 10 years. The degree oflipoatrophy in the buttocks and legs was determined by participatingphysicians. Three subjects (12.5%) exhibited mild lipoatrophy, 10subjects (41.67%) were judged as moderate, and 11 subjects (45.83%) werejudged as severe. Baseline sitting comfort decreased as the degree oflipoatrophy severity increased as shown in Table 1:

TABLE 1 Sitting Comfort & Degree of Lipoatrophy Baseline Sitting Degreeof Lipoatrophy Number of Subjects Comfort (minutes) Mild 3 23 Moderate10 13 Severe 11 7 Mean of all categories 11.58

Sitting Comfort

The study demonstrated a statistically significant increase in sittingcomfort. At baseline, subjects were able to sit comfortably for a meanof 11.58 minutes. At the two month conclusion of the study, meancomfortable sitting time had increased to 189 minutes (p=0.0001). FIG. 6illustrates the significant change in mean length of sitting comforttime.

Sleep Restlessness

Sleep restlessness improved significantly (p=0.0008). 16 of the 24patients improved one or more levels, 6 stayed the same and 2 reportedincreased restlessness as shown in Table 2.

TABLE 2 Change in Sleep Restlessness Baseline Month 2 Matched PairsWilcoxon Sign- Mean Mean Difference T-Test Prob < t Rank Prob < Z2.66676 1.75000 −.09167 .0008 .001

Quality of Life

All four Domains of the Quality of Life evaluated improved over the 2month study. The study demonstrated a statistically significant increasein the mean scores of two Domains, Physical Function and Social Function(p=0.02). The mean scores of the Mental Health and Cognitive FunctionDomains improved at the p=0.1 level as can be taken from Table 3.

TABLE 3 Quality of Life Composite Domain Analysis Wilcoxon Month 2Matched Pairs Sign-Rank Variable Baseline Mean Mean Difference T-testProb > t Prob > Z Mental Health Domain Total 18.08 19.39 1.31 0.1050.072 Physical Function Domain Total 17.88 20.13 2.26 0.020 0.032 SocialFunction Domain Total 19.17 20.83 1.65 0.023 0.019 Cognitive FunctionDomain 20.38 21.57 1.19 0.110 0.290 Total

When the 4 questions in each Domain were analyzed individually, thesample means of 15 out of 16 questions improved, and one remainedunchanged. In the Mental Health Domain, depression improvedsignificantly (p=0.045). In the Physical Function Domain, doing morearound the house and doing more outside the house improved significantly(p=0.007 and 0.014 respectively). In the Social Function Domain, feelingisolated, lacking energy to socialize and spending quality time withfriends improved significantly (p=0.043, 0.035, and 0.004 respectively).In the Cognitive Function Domain, trouble remembering things and shortattention span improved at the p=0.058 and 0.082, respectively, as canbe seen from Table 4.

TABLE 4 Domain Question Analysis Wilcoxon Month 2 Matched PairsSign-Rank Baseline Mean Mean Difference T-test Prob > t Prob > Z MentalHealth Q1 “You felt depressed” 4.87 5.43 0.57 0.045 0.019 Q2 “You feltanxious” 5.09 5.43 0.35 0.194 0.205 Q3 “You felt needed” 3.91 3.96 0.040.439 0.443 Q4 “You worried about things” 4.13 4.57 0.43 0.102 0.090Physical Function Q9 “do things around house” 4.52 5.43 0.91 0.007 0.008Q10 “get from place to place” 5.35 6.00 0.65 0.014 0.016 Q 11 “climbstairs” 5.17 5.22 0.04 0.454 0.608 Q 12 “perform strenuous 3.13 3.480.35 0.143 0.176 sports” Social Function Q 13 “You felt isolated” 4.955.45 0.50 0.043 0.060 Q 14 “withdrawn from 5.18 5.18 0.00 0.500 0.531socializing” Q 15 “lacked energy to 4.73 5.27 0.55 0.035 0.047socialize: Q 16 “spent quality time with 4.23 4.91 0.68 0.004 0.006friends” Cognitive Function Q 21 “trouble remembering 4.83 5.26 0.430.058 0.065 things” Q 22 “forgetting what you 4.96 5.17 0.22 0.244 0.250started” Q 23 “mind wanders” 5.13 5.35 0.22 0.229 0.258 Q 24 “shortattention span” 5.30 5.78 0.48 0.082 0.123

As a result of sitting pain relief, subjects reported being able toparticipate longer and concentrate better in a wide variety ofactivities including: choir, church, computer time, concerts, doingbills, driving, meditation, meetings, movies, plane travel, reading,restaurants, school, seminars, shopping, socializing, theater, walking,watching TV, work, writing letters, yard work and yoga. This expansionin activities contributed to the improved Quality of Life Rating scalesin the multiple domains noted above.

In general, subjects also reported decreased use of pain medications,rated the quality of their life as improved significantly, rated theirappearance as improved significantly and to rated the product as veryuseful. Multiple comments were received from the subjects as to theimportance of the padded shorts restoring a normal body contour whichresulted in an improved appearance. 100% would recommend the product toothers.

Discussion

The emergence of lipoatrophy and subsequently sitting pain as animportant clinical component of long term HIV treated subjects has leadto the recognition of the impact of sitting pain on the lives of thesesubjects. As a result of this often debilitating sitting pain,withdrawal from activities increases which results in a decreasedquality of life. This study shows that a discreet, anatomicallydesigned, padded undergarment allows subjects extended sitting comfortand improved appearance which in turn allows them to return toactivities reduced or abandoned and increases the quality of life.LipoWear Shorts significantly improved sitting pain comfort andappearance and significantly increased the quality of life in subjectswith lipoatrophy and sitting pain

Thus, specific embodiments and applications of functional undergarmentshave been disclosed. It should be apparent, however, to those skilled inthe art that many more modifications besides those already described arepossible without departing from the inventive concepts herein. Theinventive subject matter, therefore, is not to be restricted except inthe spirit of the appended claims. Moreover, in interpreting both thespecification and the claims, all terms should be interpreted in thebroadest possible manner consistent with the context. In particular, theterms “comprises” and “comprising” should be interpreted as referring toelements, components, or steps in a non-exclusive manner, indicatingthat the referenced elements, components, or steps may be present, orutilized, or combined with other elements, components, or steps that arenot expressly referenced. Furthermore, where a definition or use of aterm in a reference, which is incorporated by reference herein isinconsistent or contrary to the definition of that term provided herein,the definition of that term provided herein applies and the definitionof that term in the reference does not apply.

1. An item of manufacture, comprising: a form-fitted undergarmentcomprising a waist portion having a waist circumference and a legportion having a leg circumference, wherein a ratio of the waistcircumference to the leg circumference is higher than a normal ratio;and a padded area that is configured to provide protection extendingfrom an upper area of the waist portion to a lower area of the legportion such that buttocks and legs of a person contacting a seat whilesitting on a chair are substantially completely covered by the paddedarea.
 2. The item of claim 1 wherein at least one of the waist portionand the leg portion comprises an elastic material.
 3. The item of claim1 wherein the ratio is characteristic of a person diagnosed with atleast one of lipoatrophy, lipodystrophy, and sarcopenia.
 4. The item ofclaim 1 wherein the ratio is further characteristic of the persondiagnosed with at least one of an HIV infection, a neoplastic disease,advanced age, and chronic diabetes.
 5. The item of claim 1 wherein theratio is at least 1.9.
 6. The item of claim 1 wherein the ratio is atleast 2.0.
 7. The item of claim 1 wherein the padded area extends to asubstantially topmost end of the waist portion.
 8. The item of claim 1wherein the padded area extends to a substantially lowermost end of theleg portion.
 9. The item of claim 1 wherein the padded area isconfigured as an independent right and left area, and wherein each areaincludes a removable pad.
 10. The item of claim 1 wherein the paddedarea comprises a plurality of vent openings and is further contoured tohave a thicker than average thickness in a buttock area.
 11. The item ofclaim 10 wherein the padded area is further contoured to have a thinnerthan average thickness in a peripheral area of the padded area.
 12. Amethod of providing symptomatic relief for a person suffering from atleast one of HIV infection, chronic diabetes, neoplastic disease,lipoatrophy, lipodystrophy, and sarcopenia comprising a step ofproviding the form-fitted undergarment according to claim
 1. 13. Themethod of claim 12 wherein the ratio is at least 1.9.
 14. The method ofclaim 12 wherein the ratio is at least 2.0.
 15. The method of claim 12wherein the padded area is configured as an independent right and leftarea, and wherein each area includes a removable pad.
 16. The method ofclaim 12 wherein the padded area comprises a plurality of vent openingsand is further contoured to have a thicker than average thickness in abuttock area.
 17. A method of providing improved sitting comfort to aperson, comprising: providing a form-fitted undergarment comprising awaist portion and a leg portion, and further comprising a padded area;wherein the padded area is configured to provide protection extendingfrom an upper area of the waist portion to a lower area of the legportion such that buttocks and legs of a person contacting a seat whilesitting on a chair are substantially completely covered by the paddedarea; and informing the person that the undergarment provides reductionin at least one of pain, numbness, local hemostasis, and deep veinthrombosis when the garment is worn during a period of sitting over atleast three hours.
 18. The method of claim 17 wherein the padded areahas an average thickness of between 0.5 inch to 1 inch.
 19. The methodof claim 17 wherein the padded area is contoured to have a thinner thanaverage thickness in a peripheral area of the padded area.
 20. Themethod of claim 17 wherein the padded area is configured as anindependent right and left area, and wherein each area includes aremovable pad.